Optimal intravascular ultrasound (IVUS)–guided second-generation drug-eluting stent (DES) implantation significantly improves clinical outcomes in all-comer patients when compared with angiography-guided DES implantation, according to a recent study published in the Journal of the American College of Cardiology. This is the first report of benefits associated with IVUS guidance over angiography guidance in all-comers in a large population.
In this study, the researchers assessed the efficacy and safety of IVUS-guided vs angiography-guided second-generation DES implantation (randomized in 1:1 ratio) in all-comer patients with coronary artery disease across 8 Chinese centers (N=1448) between August 2014 and May 2017. The researchers determined IVUS-guided DES implantation to be successful only if all prespecified IVUS-defined criteria for the optimal stent deployment were met.
Participants were included in the study if they had silent ischemia, stable or unstable angina, or myocardial infarction (both ST-segment and non–ST-segment elevation) within 24 hours post-onset of chest pain to admission, and a de novo coronary lesion eligible for DES implantation.
There were 6 exclusion criteria: antithrombotic therapy intolerance; significant anemia, thrombocytopenia, or leucopenia; comorbidity with a life expectancy of less than 12 months; personal history of major hemorrhage; chronic total occlusion lesion in specific areas of the coronary artery; and severe arterial calcification.
The primary endpoint of the study was defined as target-vessel failure (TVF) upon 12 months post-procedure. Major secondary endpoints were defined as all-cause death, myocardial infarction, target-lesion revascularization, in-stent restenosis, stroke, and each primary endpoint component (composite of cardiac death, target-vessel myocardial infarction, and clinically driven target-lesion revascularization). Clinical events were assessed by a double-blinded independent events committee.
The researchers hypothesized, based on previous studies, that the rate of a 1-year or 12-month TVF would be 2.9% in the IVUS-guided group versus 6.1% in the angiography-guided group. The primary endpoint difference between the groups was compared using the Cox proportional hazard model.
At 12 months, 2.9% of TVFs occurred in the IVUS-guided group versus 5.4% in the angiography group (hazard ratio [HR], 0.530; 95% CI, 0.312–0.901; P =.019).
Regarding optimal stent deployment criteria, TVF occurred in 1.6% of participants who achieved all optimal criteria vs 4.4% of participants who did not achieve all optimal criteria (HR, 0.349; 95% CI, 0.135–0.898; P =.029).
The researchers noted several study limitations, which included but were not limited to the fact that the researchers did not directly compare the rate of TVF in stratified form based on the different IVUS-defined criteria, and the study did not assess cardiac events after 12 months of follow-up.
Despite these limitations, the researchers were able to conclude that IVUS-guided DES implantation led to a decreased occurrence of TVF at 12 months in all-comer patients.
Zhang J, Gao X, Kan J, et al. Intravascular ultrasound versus angiography-guided drug-eluting stent implantation, the ULTIMATE Trial. [published online September 17, 2018]. J Am Coll Cardiol. doi:10.1016/j.jacc.2018.09.013